title: Phase II study of S-1 monotherapy in patients over 75 years of age with advanced gastric cancer (OGSG0404).
abstract: BACKGROUND
  S-1+cisplatin (CDDP) is the standard treatment for advanced gastric cancer (AGC) in Japan and Korea. However, the usefulness of S-1 based chemotherapy for elderly patients is unclear. Therefore, we conducted a multicenter phase II study of S-1 monotherapy for AGC in elderly patients.
  
  
  METHODS
  Chemotherapy-naïve patients aged over 75 years with AGC were enrolled. The starting dose of S-1 was determined on the basis of body surface area and modified according to the creatinine clearance value. S-1 was administered twice a day during a 4-week period followed by a 2-week rest period.
  
  
  RESULTS
  Thirty-five patients were enrolled. The response rate (RR) was 14.3% and the median overall survival was 14.6 months. Grade 3 or more severe adverse events consisted of anaemia (3%), neutropaenia (3%), anorexia (3%), and fatigue (6%). There were no treatment-related deaths.
  
  
  CONCLUSIONS
  Our study indicates that S-1 monotherapy is safe and well tolerated in chemotherapy-naïve elderly patients with AGC, but exerts limited activity when given using a tailor-made dosing strategy based on renal function.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.forename: Tomono
authors.initials: T
authors.lastname: Kishimoto
authors.forename: Hiroya
authors.initials: H
authors.lastname: Takiuchi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.forename: Takashi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Motohiro
authors.initials: M
authors.lastname: Imano
authors.forename: Shohei
authors.initials: S
authors.lastname: Iijima
authors.forename: Keishi
authors.initials: K
authors.lastname: Yamashita
authors.forename: Kentaro
authors.initials: K
authors.lastname: Maruyama
authors.forename: Toshio
authors.initials: T
authors.lastname: Otsuji
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Furukawa
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000627:therapeutic use*; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D005641:Tegafur / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid
keywords: Elderly,; Gastric cancer,; Phase II study; S-1 monotherapy,